argenx gets FDA nod for Vyvgart as gMG treatment
The US Food and Drug Administration (FDA) has approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, said Belgo-Dutch clinical-stage immune-oncology biotech argenx (Euronext Brussels: ARGX).
Shares of Argenx rose 4.4% to $310.26 on December 17 ahead of a trading halt triggered just ahead of the announcement.
These patients represent approximately 85% of the total gMG population. With this regulatory milestone, Vyvgart is the first-and-only FDA-approved neonatal Fc receptor (FcRn) blocker, the company noted. However, Vyvgart will still compete with already blockbuster Solaris (eculizumab), from now AstraZeneca (LSE: AZN) subsidiary Alexion.
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